Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective To investigate the relationship between interleukin-1β (IL-1β) and miR-185-5p in the process of joint injury in acute gouty arthritis (AGA). Methods The serum miR-185-5p levels of 89 AGA patients and 91 healthy volunteers were detected by real-time quantitative PCR. The correlation between miR-185-5p expression level and VAS score or IL-1β expression level was evaluated by Pearson correlation coefficient method. Receiver operating characteristic (ROC) curve was used to evaluate the diagnostic value of miR-185-5p in AGA. THP-1 cells were induced by sodium urate (MSU) to construct an in vitro acute gouty inflammatory cell model. After the expression level of miR-185-5p in THP-1 cells was upregulated or downregulated by transfection of miR-185-5p mimics or inhibitors in vitro, inflammatory cytokines of THP-1 cells, such as IL-1β, IL-8 and tumor necrosis factor α (TNF-α), were detected by ELISA. The luciferase reporter gene assay was used to determine the interaction between miR-185-5p and the 3'-UTR of IL-1β. Results Compared with the healthy control group, the expression level of serum miR-185-5p in AGA patients was significantly reduced. The level of serum miR-185-5p was negatively correlated with VAS score and IL-1β expression level. The area under the curve (AUC) was 0.905, the sensitivity was 80.17% and the specificity was 83.52%. Down-regulation of miR-185-5p significantly promoted the expression of IL-1β, IL-8 and tumor necrosis factor (TNF-α), while overexpression of miR-185-5p showed the opposite results. Luciferase reporter gene assay showed that IL-1β was the target gene of miR-185-5p, and miR-185-5p negatively regulated the expression of IL-1β. Conclusion miR-185-5p alleviates the inflammatory response in AGA by inhibiting IL-1β.
Humans ; 3' Untranslated Regions ; Arthritis, Gouty/genetics* ; Interleukin-1beta/genetics* ; Interleukin-8 ; Luciferases ; MicroRNAs/genetics* ; Tumor Necrosis Factor-alpha

Objective To explore the impact of adipokine metabolism on coronary microvascular dysfunction(MVD)and the clinical application value of Shexiang Tongxin dropping pill(STDP).Methods From Sep.2018 to Dec.2019,41 patients with coronary heart disease in Department of Cardiology,Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine were enrolled and divided into non-MVD group(20 cases)and MVD group(21 cases);29 MVD patients were randomly divided into basic treatment group(14 cases)and STDP group(15 cases)with basic treatment or additional STDP treatment for 3 months;and the patient's complaints,blood biochemical indicators,expression levels of plasma inflammatory factors and adipokines were analyzed.A myocardial ischemia-reperfusion model was established in male C57BL/6 mice aged 12-14 weeks.Mice were divided into sham operation group,ischemia-reperfusion(IR)group(normal saline gavage),and IR+STDP group(STDP gavage),with 5 mice in each group.The levels of plasma inflammatory factors were measured by enzyme-linked immunosorbent assay,the microvascular occlusion of the heart tissue was measured by thioflavin-S staining,and the differential expression proteins between the IR group and IR+STDP group were explored by proteomics analysis and verified by Western blotting.Results Compared with the non-MVD group,the MVD group showed a significant increase in plasma leptin level([9.89±2.42]μg/L vs[4.76±1.02]μg/L,P＜0.01),a significant decrease in adiponectin level([5.02±1.3]pg/mL vs[7.19±1.76]pg/mL,P＜0.05),and a significant increase in resistin level([9.20±2.03]μg/L vs[5.70±1.32]μg/L,P＜0.05).Pearson correlation analysis showed a positive correlation between leptin levels and MVD(r=0.82 and P＜0.01).Receiver operating characteristic curve analysis showed that the area under curve value of plasma leptin was 0.855(sensitivity 0.714,specificity 0.867,and optimal cutoff value＞9.395 μg/L).After 3 months of treatment,compared with the basic treatment group,the improvement rates of symptoms of chest distress and chest pain in the STDP group were significantly higher(73.3％[11/15]vs 21.4％[3/14]),and the levels of plasma leptin,interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)were significantly lower([11.36±0.54]μg/L vs[12.12±0.85]μg/L,[3.96±1.76]pg/mL vs[8.65±1.29]pg/mL,[24.82±3.07]ng/mL vs[32.45±3.32]ng/mL,all P＜0.05).In animal studies,compared with the IR group,the mice in the IR+STDP group showed a 45％reduction in no-reflow area(P＜0.01)and a 23％reduction in low-reflow and no-reflow areas(P＜0.05)after myocardial ischemia-reperfusion;the expression levels of IL-6 and TNF-α were significantly decreased([378.25±19.66]pg/mL vs[457.32±32.01]pg/mL,[289.71±47.62]pg/mL vs[371.28±41.05]pg/mL,both P＜0.05).Proteomic analysis showed that the expression levels of von Willebrand factor(vWF)and intercellular cell adhesion molecule-1(ICAM-1)in the cardiac tissue of mice in the IR+STDP group were significantly lower than those in the IR group.Western blotting results also showed that the expression levels of vWF and ICAM-1 in the IR+STDP group were significantly lower than those in the IR group(both P＜0.01).Conclusion MVD patients have abnormal adipokine metabolism and high plasma leptin.STDP can improve clinical symptoms of MVD patients,reduce the plasma leptin level and inflammatory indicators,and the mechanism may be related to its antiplatelet and anti-inflammatory effects.

Objective To predict the potential suitable distribution areas of Sophora japonica cv.jinhuai in China;To provide a references for resource development and expanded cultivation of Sophora japonica cv.jinhuai.Methods Totally 85 pieces of information on the distribution of sample sites were collected and combined data on 72 environmental factors,and the dominant environmental factors affecting the suitability distribution of Sophora japonica cv.jinhuai were analyzed using the maximum entropy(MaxEnt)model and geographic information system software ArcGIS.Results The five dominant environmental factors influencing the suitability distribution of Sophora japonica cv.jinhuai were dry month precipitation,May light radiation,November precipitation,September mean temperature,and October light radiation.The potentially suitable distribution area of Sophora japonica cv.jinhuai in China was mainly concentrated in the transition zone between south-central Hunan Province and northeast Guangxi Zhuang Autonomous Region.Conclusion The results of this study can provide references for the selection of the cultivation areas of Sophora japonica cv.jinhuai and protection of wild reso of Sophora japonica cv.jinhuai.

Objective:To evaluate percutaneous mechanical thrombectomy (PMT) using Aspirex device for treating acute iliofemoral deep vein thrombosis (IFDVT).Methods:The clinical and follow-up data of 68 patients with IFDVT at our institution from Jan 2019 to Jun 2021 was retrospectively analyzed.Results:Twenty-six patients who had received PMT combined with auxiliary catheter directed thrombolysis (CDT) were included into group A, and 42 patients received CDT alone were into group B.The final thrombus clearance rates were more than 50%, and the clinical efficacy of thrombolysis was achieved. Group A associated a significant reduction in lysis duration and UK dosage and hospital days and degree of detumescence after 24 h compared with group B,and all aforementioned differences were statistically significant. Hospitalization costs in group A were more than group B. At one year follow-up, there were no significant differences between the two groups in the cumulative prevalence post-thrombotic syndrome (PTS) and the Villalta score and primary patency (92.0% vs. 90.0% , χ2=0.059, P=0.807). Conclusions:The application of PMT using the Aspirex device for acute IFDVT was safe and effective, which could accelerate the clearance of thrombus, and reduce UK dosage, lysis duration, hospital days. However, it increased the hospitalization costs.

Objective:To describe the characteristics and medical seeking behaviors of female infertility patients in assisted reproductive institutions in China overall and geographical regions, and compare the differences among the eastern, the middle and the western regions.Methods:This study used the data from Unit 6-Analysis on the matching status of reproductive health and health care services among reproductive age population and demonstration and promotion study of diagnosis and treatment in National Key R&D Program "Reproductive Health and Major Birth Defects Prevention and Control Study" participated by the Assisted Reproductive Technology Management Department of Maternal and Child Health Care Center, Chinese Center for Disease Control and Prevention. One assisted reproductive institution with more than 1 000 and less than 1 000 oocyte retrieval cycles by in vitro fertilization techniques in 2018 was selected from 8 provincial capital cities in different regions of eastern and western China, and the questionnaire data of infertile female patients aged 20-49 years who first visited the outpatient clinics of 16 institutions were analyzed. The patient's age, degree of culture, annual personal income, try-to-conceived time, and one-way transportation time were analyzed using the frequency description, χ 2 test, Kruskal-Wallis H test and other methods. Results:A total of 3 673 female patients were finally included as study subjects. The patient's age was (31.0±4.6) years old, and 59.0% (2 156/3 660) was an undergraduate/college degree or above, with a median pregnancy test duration of 2.0 (1.3, 3.5) years. In terms of demographic characteristics, the proportion of patients over 35 years old in the eastern and western regions was greater in small institutions, 22.8% (216/948) and 26.4% (148/561), respectively. The proportion of patients with academic degrees in high school and below in the central region was higher, 49.1% (216/440) in large institutions and 47.0% (275/585) in small institutions. In terms of economics, 30.5% (521/1 708) of eastern patients reached an annual income of more than RMB 100 000, while only 2.8% (26/939) were willing to accept more than RMB 100 000 in treatment costs, and patients in the central and western regions were lower than those in the eastern region in terms of their annual income and acceptable treatment costs ( P<0.001). In terms of transportation, patients in the western region spent the longest amount of one-way transportation time, with large institutions of 30.9% (117/379) and small institutions of 29.8% (167/561) needing to spend more than 3 h; the proportion of patients in the eastern region who seek medical treatment from overseas was the highest, with 21.6% (164/758). Conclusion:The age of infertility patients in assisted reproductive institutions in China generally exceeds the optimal reproductive age of women and has a higher degree of education. Therefore, in young and people with a lower degree of education, the publicity of reproductive knowledge should be strengthened to encourage couples with fertility willingness to start preparation as early as possible. ln addition, there are more older patients in the western region, as well as the economic and transportation conditions are more unfavorable, and more attention needs to be paid at the policy level.

Objective:To describe the characteristics and medical seeking behaviors of female infertility patients in assisted reproductive institutions in China overall and geographical regions, and compare the differences among the eastern, the middle and the western regions.Methods:This study used the data from Unit 6-Analysis on the matching status of reproductive health and health care services among reproductive age population and demonstration and promotion study of diagnosis and treatment in National Key R&D Program "Reproductive Health and Major Birth Defects Prevention and Control Study" participated by the Assisted Reproductive Technology Management Department of Maternal and Child Health Care Center, Chinese Center for Disease Control and Prevention. One assisted reproductive institution with more than 1 000 and less than 1 000 oocyte retrieval cycles by in vitro fertilization techniques in 2018 was selected from 8 provincial capital cities in different regions of eastern and western China, and the questionnaire data of infertile female patients aged 20-49 years who first visited the outpatient clinics of 16 institutions were analyzed. The patient's age, degree of culture, annual personal income, try-to-conceived time, and one-way transportation time were analyzed using the frequency description, χ 2 test, Kruskal-Wallis H test and other methods. Results:A total of 3 673 female patients were finally included as study subjects. The patient's age was (31.0±4.6) years old, and 59.0% (2 156/3 660) was an undergraduate/college degree or above, with a median pregnancy test duration of 2.0 (1.3, 3.5) years. In terms of demographic characteristics, the proportion of patients over 35 years old in the eastern and western regions was greater in small institutions, 22.8% (216/948) and 26.4% (148/561), respectively. The proportion of patients with academic degrees in high school and below in the central region was higher, 49.1% (216/440) in large institutions and 47.0% (275/585) in small institutions. In terms of economics, 30.5% (521/1 708) of eastern patients reached an annual income of more than RMB 100 000, while only 2.8% (26/939) were willing to accept more than RMB 100 000 in treatment costs, and patients in the central and western regions were lower than those in the eastern region in terms of their annual income and acceptable treatment costs ( P<0.001). In terms of transportation, patients in the western region spent the longest amount of one-way transportation time, with large institutions of 30.9% (117/379) and small institutions of 29.8% (167/561) needing to spend more than 3 h; the proportion of patients in the eastern region who seek medical treatment from overseas was the highest, with 21.6% (164/758). Conclusion:The age of infertility patients in assisted reproductive institutions in China generally exceeds the optimal reproductive age of women and has a higher degree of education. Therefore, in young and people with a lower degree of education, the publicity of reproductive knowledge should be strengthened to encourage couples with fertility willingness to start preparation as early as possible. ln addition, there are more older patients in the western region, as well as the economic and transportation conditions are more unfavorable, and more attention needs to be paid at the policy level.

Objective    To evaluate the clinical effects of segmentectomy versus lobectomy under single utility port video-assisted thoracic surgery on inflammatory factors and immune cells in peripheral blood of non-small cell lung cancer patients, and to analyze the effect of changes of postoperative inflammatory factors and immune cells on the prognosis of the patients. Methods    The clinical data of 256 patients who underwent segmentectomy or lobectomy under single utility port video-assisted thoracic surgery for non-small cell lung cancer in the First Affiliated Hospital of Hebei North University from January 2016 to October 2020 were retrospectively collected. According to the operation method, they were divided into a segmentectomy group (126 patients with 79 males and 47 females at an age of 63.4±6.2 years) and a lobectomy group (130 patients with 91 males and 39 females at an age of 62.9±5.6 years). The change of inflammatory factors (C reactive protein, interleukin-6, interleukin-8, tumor necrosis factor-α) and immune cells (CD4+T cells, CD8+T cells and natural killer cells) were recorded and analyzed before operation (T0) and 1 day (T1), 3 days (T2), 7 days (T3), 1 month (T4) after the operation between the two groups. According to postoperative recurrence situations, they were divided into a recurrence group and a non-recurrence group, multivariate logistic regression analysis was used to analyze the relationship between the change of postoperative inflammatory factors, immune cells, and the prognosis of patients with non-small cell lung cancer. Results    (1) There was no statistical difference in sex ratio, underlying diseases, body mass index, levels of preoperative inflammatory factors or immune cells between the two groups (all P>0.05). (2) The changes of postoperative inflammatory factors in the segmentectomy group were significantly less than those in the lobectomy group at T1-T3 (all P<0.05), and the changes of postoperative immune cells in the segmentectomy group were significantly less than those in the lobectomy group at T1-T4 (all P<0.05). (3) The changes of postoperative inflammatory factors and immune cells on postoperative day 3 in the recurrence group were significantly more than those in the non-recurrence group (all P<0.05). (4) Multivariate logistic regression analysis showed that the changes of postoperative inflammatory factors and immune cells on postoperative day 3 may be the risk factors for postoperative recurrence and metastasis in patients with non-small cell lung cancer (all P<0.05). Conclusion    Single utility port video-assisted thoracic surgery segmentectomy for the treatment of non-small cell lung cancer can reduce the inflammatory response and protect body's immune function, and the change of postoperative inflammatory factors and immune cells in postoperative day 3 may be the risk factors for postoperative recurrence and metastasis in patients with non-small cell lung cancer.